August 22, 2022: IMPACt-LBP Awarded Continuation to Implementation Phase

IMPACt-LBP investigatorsThe NIH Pragmatic Trials Collaboratory is pleased to announce that the IMPACt-LBP NIH Collaboratory Trial received approval this month to transition from the planning phase to the implementation phase. This pragmatic clinical trial embedded in healthcare systems is studying implementation of guideline-based care for low back pain, a leading cause of ambulatory care visits in the United States.

Congratulations to the IMPACt-LBP investigators and their study teams for reaching this important milestone!

IMPACt-LBP will evaluate implementation of the American College of Physicians guideline for low back pain, which involves multidisciplinary collaborative care that includes doctors of chiropractic and physical therapists. The study will measure the effects of first-contact patient referral to these clinicians on physical function, pain, opioid prescriptions, and other patient-level outcomes.

Logo for the IMPACt-LBP NIH Collaboratory TrialThe study is administered by the National Center for Complementary and Integrative Health with additional support from the National Institute of Arthritis and Musculoskeletal and Skin Diseases and the National Institute of Child Health and Human Development. The project is led by Drs. Christine Goertz, Adam Goode, and Hrishikesh Chakraborty of Duke University and Dr. Jon Lurie of Dartmouth Hitchcock Medical Center.

Learn more about IMPACt-LBP.

October 21, 2021: NIH Collaboratory Launches IMPACt-LBP NIH Collaboratory Trial

IMPACt-LBP investigatorsThe NIH Collaboratory is excited to announce the addition of a new large-scale pragmatic clinical trial to its portfolio: Implementation of the American College of Physicians Guideline for Low Back Pain (IMPACt‑LBP). Co-led by investigators at the Duke Clinical Research Institute, IMPACt-LBP is a pragmatic, multisite, 2-arm cluster randomized trial that will evaluate the effect of a multidisciplinary collaborative team approach for low back pain (LBP) versus usual care. In the intervention arm, patients with a primary complaint of LBP will be referred to physical therapists and chiropractic doctors—or primary spine practitioners (PSPs)—as first-line providers.

This study aims to determine if initial contact with PSP clinicians will improve physical function, decrease pain, decrease opioid prescriptions, improve patient satisfaction, and decrease costs and utilization of health care services in patients with a primary complaint of LBP, when compared with usual medical care.

NIH Collaboratory Trials are multicenter, pragmatic trials that are embedded in healthcare delivery systems to gather real-world evidence and answer clinical questions of major public health importance. In its first 10 years, the NIH Collaboratory successfully engaged with 21 complex NIH Collaboratory Trials. IMPACt-LBP will join 6 other NIH Collaboratory Trials that focus on pain as part of a broader effort to reduce opioid prescribing and inform policy.

The results from this study will directly inform implementation and policy efforts to improve the quality of pain management for patients suffering from LBP while simultaneously reducing opioid prescriptions, health care costs and utilization of services.

The study is supported within the NIH Collaboratory by the National Center for Complementary and Integrative Health, with additional support from the National Institute of Arthritis and Musculoskeletal and Skin Diseases and the National Institute of Child Health and Human Development.

 

 

November 20, 2018: Upcoming NIH Funding Opportunity Announcements for Pragmatic Trials Address the Opioid Crisis

The NIH has announced an intent to publish new funding opportunity announcements (FOAs) for 5 or more embedded pragmatic clinical trials that address pain management and the opioid crisis. These projects will become part of the NIH Health Care Systems Research Collaboratory as phased UG3/UH3 cooperative research. Both FOAs will be published in early December with applications due as early as February 2019.

The two notices are:

The announcements are part of the NIH Heal (Helping to End Addiction Long-term) Initiative, which was created in April 2018 in an effort to speed scientific solutions for addressing the national opioid public health crisis.

LIRE Pragmatic Clinical Trial Begins Randomization


One of the NIH Collaboratory’s initial NIH Collaboratory Trial, the Lumbar Image Reporting with Epidemiology (LIRE) study, has begun randomization in early April. The LIRE trial is designed to test whether inserting additional epidemiological information into the lumbar spine imaging reports of patients being treated for lower back pain can help both doctors and patients to better understand and interpret the reports. This in turn could help doctors avoid subjecting patients to unnecessary tests and procedures.

LIRE is a cluster randomized trial, which means that instead of randomizing individual patients, whole clinics (one at the Henry Ford Health System in Detroit; one at Group Health Cooperative in Seattle, with more to follow) are randomly assigned to provide either the experimental treatment or the control treatment to patients.

Cluster-randomized trials offer a number of advantages, including the avoidance of certain kinds of bias that can effect the outcome of a study, but they also raise special issues that can require careful consideration.

The principal investigator of the LIRE trial is Dr. Jeffrey Jarvik  of the University of Washington. You can read more about the LIRE trial here.